Evidence map›Paper›PMID 37042978›Full record

ArticleInflammatory bowel diseases2024

Dual Biologic or Small Molecule Therapy in Refractory Pediatric Inflammatory Bowel Disease (DOUBLE-PIBD): A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN.

Anat Yerushalmy-Feler, Christine Olbjorn, Kaija-Leena Kolho, Marina Aloi, Francesca Musto, Javier Martin-de-Carpi, Ana Lozano-Ruf, Dotan Yogev, Manar Matar, Luca Scarallo and 8 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyComment
PubMed Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06520397 (Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab), which is not on this map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
11.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06520397 phase4recruitingnot on this map

Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab: A Randomized Controlled Trial

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2024 to 2027Enrolled214ConditionsCrohn DiseaseArmsUstekinumab and Upadacitinib, Ustekinumab
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025
    Guideline
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Article
  11. Effectiveness and safety of upadacitinib in refractory pediatric inflammatory bowel disease: A single-arm meta-analysis of observational studies.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  12. Review
  13. Article
  14. [Research progress on biologics and therapeutic drug monitoring in pediatric inflammatory bowel disease].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025
    Review
  15. Article
  16. Article
  17. Article
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  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 13 institutions in 10 countries.

Anat Yerushalmy-FelerPediatric Gastroenterology Institute, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Christine OlbjornDepartment of Paediatric and Adolescent Medicine, Akershus University Hospital, Lørenskog, Norway.
Kaija-Leena KolhoDepartment of Paediatric Gastroenterology, Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Marina AloiDepartment of Maternal and Child Health, Pediatric Gastroenterology and Liver Unit, Umberto I Hospital, Sapienza University of Rome, Rome, Italy.ORCID 0000-0001-7404-4004
Francesca MustoDepartment of Maternal and Child Health, Pediatric Gastroenterology and Liver Unit, Umberto I Hospital, Sapienza University of Rome, Rome, Italy.
Javier Martin-de-CarpiDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, Hospital Sant Joan de Déu, Barcelona, Spain.
Ana Lozano-RufDepartment of Pediatric Gastroenterology, Hepatology and Nutrition, Hospital Sant Joan de Déu, Barcelona, Spain.
Dotan YogevJuliet Keiden Institute of Pediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Manar MatarInstitute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Luca ScaralloGastroenterology and Nutrition Unit, Meyer Children's Hospital, Florence, Italy.
Matteo BramuzzoGastroenterology, Digestive Endoscopy and Nutrition Unit, Institute for Maternal and Child Health, IRCCS Burlo Garofolo, Trieste, Italy.ORCID 0000-0002-5249-8248
Lissy de RidderDepartment of Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Ben KangDepartment of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Korea.
Christoph NordenPaediatric Department, Copenhagen University Hospital, Hvidovre, Denmark.
David C WilsonDepartment of Paediatric Gastroenterology and Nutrition, Royal Hospital for Children and Young People, Edinburgh, United Kingdom.
Christos TzivinikosAl Jalila Children's Specialty Hospital, Dubai, United Arab Emirates.
Dan TurnerJuliet Keiden Institute of Pediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Shlomi CohenPediatric Gastroenterology Institute, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.ORCID 0000-0002-6190-3217
Tel Aviv University · ILHebrew University of Jerusalem · ILHospital Sant Joan de Déu Barcelona · ESPoliclinico Umberto I · ITAkershus University Hospital · NOAl Jalila Foundation · AECopenhagen University Hospital · DKErasmus MC - Sophia Children’s Hospital · NLIRCCS Materno Infantile Burlo Garofolo · ITKyungpook National University · KRMeyer Children's Hospital · ITRoyal Hospital for Children · GBUniversity of Helsinki · FI

Funding

Helsinki University Hospital Research FundPediatric Research Foundation
6 · The paper itself

Abstract

backgroundCurrent data on dual biologic therapy in children are limited. This multicenter study aimed to evaluate the effectiveness and safety of dual therapy in pediatric patients with inflammatory bowel disease (IBD).

methodsA retrospective study from 14 centers affiliated with the Pediatric IBD Interest and Porto Groups of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Included were children with IBD who underwent combinations of biologic agents or biologic and small molecule therapy for at least 3 months. Demographic, clinical, laboratory, endoscopic, and imaging data were collected. Adverse events were recorded.

resultsSixty-two children (35 Crohn's disease, 27 ulcerative colitis; median age 15.5 [interquartile range, 13.1-16.8] years) were included. They had all failed previous biologic therapies, and 47 (76%) failed at least 2 biologic agents. The dual therapy included an anti-tumor necrosis factor agent and vedolizumab in 30 children (48%), anti-tumor necrosis factor and ustekinumab in 21 (34%) children, vedolizumab and ustekinumab in 8 (13%) children, and tofacitinib with a biologic in 3 (5%) children. Clinical remission was observed in 21 (35%), 30 (50%), and 38 (63%) children at 3, 6, and 12 months, respectively. Normalization of C-reactive protein and decrease in fecal calprotectin to <250 µg/g were achieved in 75% and 64%, respectively, at 12 months of follow-up. Twenty-nine (47%) children sustained adverse events, 8 of which were regarded as serious and led to discontinuation of therapy in 6.

conclusionsDual biologic therapy may be effective in children with refractory IBD. The potential efficacy should be weighed against the risk of serious adverse events.

Indexed as

Biological ProductsColitis, UlcerativeInflammatory Bowel DiseasesAdolescentChildHumansNecrosisRetrospective StudiesUstekinumabBiological ProductsUstekinumabCrohn’s diseasedual biologicsulcerative colitis

Identifiers

PMID37042978
OpenAlexW4365135578

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.